FDA Clears Crux Biomedical's Bidirectional Retrievable Vena Cava Filter

July 18, 2012—Crux Biomedical (Menlo Park, CA) announced that it has received US Food and Drug Administration clearance for its inferior vena cava filter (VCF). 

According to the company's press release, the Crux VCF is designed to facilitate bidirectional retrieval through either the femoral or jugular veins. The device features a helical shape that self-centers and conforms closely to the shape of the vena cava; the helical shape also reduces the bends and stress that can compromise filter integrity. 

“Crux designed a device that is both more versatile and simple to use,” commented Crux Biomedical's founder Tom Fogarty, MD, in the company's announcement. “Bidirectional deployment and retrieval are extremely helpful in situations where access to either the femoral or jugular vein is not possible. The Crux VCF, with its innovative design and materials, represents a paradigm shift in prevention of pulmonary embolisms in patients at risk.”

Crux Biomedical also noted that results from the recently completed RETRIEVE clinical study were presented on March 26 at the 2012 Society for Interventional Radiology (SIR) meeting. The pivotal RETRIEVE trial was composed of 125 patients at high risk for pulmonary embolisms and was conducted at 22 sites in the United States, Australia, New Zealand, and Belgium. In the study, the technical success rate of filter deployment was 98%; filter retrieval success was also 98%. The average retrieval time was 7 minutes. At 6-month follow-up, no embolizations, device migrations, or device fractures were observed. Robert R. Mendes, MD, of the University of North Carolina, served as Principal Investigator of the study and presented the data.

At the SIR meeting, Dr. Fogarty spoke with Endovascular Today about the challenges faced in the current VCF market and the potential he sees for the Crux VCF. In addition to bidirectional retrieval ability, he sought to design a device that would prevent the in-growth and ineffectiveness that can be caused by filter tilting within the vessel, as well as a design that is very unlikely to penetrate or perforate the vessel wall. The Crux VCF is constructed with a self-expanding nitinol frame that includes two opposing spiral elements, which are connected with nitinol clamps. Its filter web is composed of expanded polytetrafluoroethylene, and five tissue anchors are attached to the spiral elements. 

The device received CE Mark approval in January 2012, the company noted.